Associate Director, Quality Control

About the role

Crescent Biopharma seeks an experienced Associate Director of Quality Control (QC) to lead QC operations across the company’s biologics pipeline. Reporting directly to the head of QC, this role involves overseeing day-to-day QC activities and analytical testing at CDMOs and CTLs. Key responsibilities include managing stability, specification, and reference standard programs, ensuring compliance with GMP requirements, and collaborating with CDMOs/CTLs to transfer and validate analytical methods.

Responsibilities

• Manage phase-appropriate stability, specification, and reference standard programs in support of early and late-stage products
• Serve as QC point of contact for CDMOs/CTLs ensuring appropriate quality control oversight of manufacturing campaigns
• Ensure CDMOs/CTLs perform release, stability, and in-process testing in accordance with GMP requirements, Crescent standards, and regulatory expectations
• Generate COAs for intermediate materials, Drug Substance/Drug Product, and collaborate with QA to facilitate batch disposition
• Monitor CDMO/CTL stability studies, review raw data, and approve stability summary reports
• Trend and evaluate stability data according to ICH in support of shelf life/expiry date assignment and extensions
• Schedule, chair, and facilitate stability review board meetings in support of stability data evaluation and assignment of product shelf-life
• Schedule, chair, and facilitate specification review board in support of new product specification and revisions
• Provide QC oversight for OOS/OOT investigations, deviations, CAPAs, and change control
• Review and approve specific sections of vendor batch records and other required documentation
• Collaborate with partners, CDMOs/CTLs to transfer methods for release and stability testing as needed according to phase appropriate approach
• Support authoring and review of Module 3 sections of regulatory submissions (IND/IMPD/BLA)
• Ensure strong data integrity practices and compliance with GMP, ICH, and global regulatory guidelines
• Assist in the establishment of QC systems, SOPs, and processes suitable for a lean and scalable operation
• Participate in internal and external cross-functional meetings as QC representative and manage program timelines
• Provide leadership, mentoring, and technical development within the QC function

Requirements

• B.S. or M.S. in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or related field
• Minimum 10 years of industry experience in biologics analytical development and QC
• Deep expertise in method qualification, validation, and lifecycle management
• Significant experience overseeing QC activities at CDMOs/CTLs
• Strong understanding of GMP, data integrity principles, and ICH analytical guidelines (Q2, Q5, Q6, Q1E)
• Experience supporting Module 3 sections of regulatory submissions and interacting with health authorities
• Experience with bioassay (Binding ELISA and Cell Based Potency (CBA) method development and life cycle management is a plus)
• Hands-on experience using Microsoft Office, Veeva Vault QualityDoc, LIMS, and Statistical software such as GraphPad Prism, JMP
• Demonstrated ability to lead QC operations in a small or virtual biotech environment
• Strong communication, leadership, and cross-functional collaboration skills

Qualifications

• Hands-on experience with stability, specification, and reference standard programs
• Proven track record overseeing external testing labs in a GMP environment
• Experience with bioassay method development and lifecycle management
• Strong understanding of GMP, data integrity principles, and ICH analytical guidelines
• Experience with regulatory submissions and interactions with health authorities
• Experience with Microsoft Office, Veeva Vault QualityDoc, LIMS, and statistical software
• Leadership and mentoring experience in a QC function

Skills

• Expertise in method qualification, validation, and lifecycle management
• Strong understanding of GMP, data integrity principles, and ICH analytical guidelines
• Experience with bioassay method development and lifecycle management
• Experience with regulatory submissions and interactions with health authorities
• Experience with Microsoft Office, Veeva Vault QualityDoc, LIMS, and statistical software
• Leadership and mentoring experience in a QC function

Benefits

Opportunity to join a mission-driven team where you'll contribute to impactful work, take on varied responsibilities, and grow quickly in a dynamic environment
Competitive compensation, including base salary, performance bonus, and equity
100% employer-paid benefits package
Flexible PTO; also, two, one-week company-wide shutdowns each year
Commitment to your professional development, with access to resources, mentorship, and growth opportunities
$160,000 - $200,000 a year
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability.
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation – Unlimited PTO; Sick time – 10 days per calendar year; Holiday pay, including two Company shut downs; Parental Leave – 16 weeks within one year of the birth/adoption/foster care of a child; FMLA; Military Leave.
Additional information can be found - https://www.crescentbiopharma.com/careers/#benefits

Pay

$160,000 - $200,000 a year

Schedule

Based in Waltham, MA